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Outsourcing and Functional Service Provider (FSP) for Medical Device Clinical Research
Companies Trust Us as Their Clinical Outsourcing Partner Because We Focus on Medical Devices…and Only Devices
You wouldn’t hire a brain surgeon to do a knee replacement so why entrust the success of your product approval to a company that doesn’t specialize in medical devices? With NAMSA, you won’t be left wondering whether the team assigned to your project fully understands your product because we have tested nearly every product type of the market and completed thousands of clinical projects. We comply with ISO 14155 and all relevant medical device regulatory requirements.
Also, we are far more than a CRO – we support our clients with a full array of market research, preclinical research, biological safety consulting, testing, and QA/RA services.
Active Annual Clinical Projects
Medical Device Clinical Professionals on Staff
Therapeutic Areas in Which We Have Experience
From startups to multinationals, medical device and IVD manufacturers are always looking for ways to achieve their goals more efficiently. Often the best way to turbocharge a project or quickly plug a gap is to look outside your organization. Ô°ÇøÒùÂÒhelps device manufacturers accelerate their goals and improve outcomes by providing a variety of clinical research outsourcing services. As a clinical Functional Service Provider and the largest CRO dedicated to medical devices, we are ready to become an extension of your team.
Why Choose Ô°ÇøÒùÂÒas Your Clinical FSP and Outsourcing Partner?
The clinical stage of your product development life cycle is arguably the most important on your road to regulatory approval. Even small mistakes early in your clinical research have severe regulatory consequences as endpoints are not met. These mistakes can delay your time to market and cost your company millions. When you work with NAMSA, you are making an investment in derisking your path to premarket approval. With Ô°ÇøÒùÂÒas your clinical trials outsourcing partner, you are getting access to the deepest team of clinical subject matter experts, all of whom focus entirely on medical devices and IVDs. We offer:
- Staff Augmentation – A flexible outsourcing solution offering you the ability to quickly respond to industry changes by increasing or decreasing staff with highly qualified Ô°ÇøÒùÂÒassociates.
- Functional Area – Designed to support Sponsors within key functional areas within clinical research. Engage with an entire area with or without management support providing you experts when and where you need them.
- Project-Based – Engage with us on a project basis with a defined scope, timeline, and deliverables with experienced Ô°ÇøÒùÂÒexperts and project management support to drive your project.
- Full Service – Ô°ÇøÒùÂÒcan support your entire clinical trial for a device using Ô°ÇøÒùÂÒexperts in every clinical research area to maximize efficiency while leveraging internal resources to support the completion of your trial.
Areas we support:
- Clinical Investigation Plan, Study Design & Protocol Development
- Clinical Trial Management
- Clinical Data Management, Data Safety and Monitoring
- Clinical Biostatistics & Real Word Evidence
- Clinical Trial Site Selection
- Clinical Study Reporting
- Pivotal and Post-Market Clinical Studies
- Medical Writing Ô°ÇøÒùÂÒ
- Clinical Site Management and monitors
- Clinical Study Management
- Clinical evaluation reports (new or updates)
- Study design, synopsis and protocol development
- PMCF surveys or study
- Biostatistics
- Data Management
- Chief Medical Officer (CMO)
- And more
Lower Your Costs and Shorten Your Time to Market
Outsourcing clinical services may initially seem costly but the payoff becomes apparent almost immediately. Our team of highly skilled clinical professionals knows exactly what needs to be done and what regulators expect. Getting it right the first time will ultimately result in your product hitting the market faster and/or maintaining compliance with US FDA, EU, or international regulations.
For companies needing a more high-touch approach, we offer our Ô°ÇøÒùÂÒAPEX PROGRAM. This is for manufacturers who want a dedicated Ô°ÇøÒùÂÒsenior account director to strategically guide the company through upcoming phases including market research, preclinical research, biological safety testing, clinical trials, and reimbursement all the way to regulatory approval.
Companies Trust Us as Their Clinical Outsourcing Partner Because We Focus on Medical Devices…and Only Devices
Request a Meeting with a Ô°ÇøÒùÂÒClinical Research Expert
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Meet Our Team of Medical Device Clinical Experts
Explore the depth of our team’s qualifications and experience.
Examples of Clinical FSP Applications and Outsourcing
Tackling a Backlog of CERsÂ
A large Japanese company with a portfolio of imaging devices needs to update a large number of clinical evaluation reports before a Notified Body surveillance audit. The existing team is fully occupied with new submission work and temporary help is needed to do literature reviews and write reports.
Conducting a PMCF SurveyÂ
A US manufacturer of wound dressings needs to conduct a post market clinical follow-up (PMCF) study. The company recently lost its Chief Medical Officer and senior management has decided that the study would best be conducted by an experienced CRO rather than trying to do it internally.
Speeding up a Clinical TrialÂ
An early-stage neurology startup has a study underway but enrollment is not happening fast enough and it is struggling to start up numerous sites. To maintain the product development timeline promised to investors, they need to accelerate enrollment and expand the number of sites.
Getting Teams on the Same PageÂ
An established cardiovascular company recently merged with another company and the two companies have not fully integrated their systems. Various departments are trying to work together to push a new product into the clinical phase but it’s moving slowly. The company needs someone to help with study startup activities and completion of a primary endpoint.
Plugging a Hole Due to Staff DeparturesÂ
A large multinational orthopedics company purchased a niche competitor and is in the process of merging clinical and regulatory operations. Numerous employees from the acquired company left soon after the acquisition but management does not want to replace them. Existing teams are overwhelmed. The parent company decides to outsource a portion of the work previously done internally to a clinical FSP.
Offering Strategic Guidance
A device manufacturer is creating an inhaler product and needs very specific expertise on FDA pharma and biologics regulations to guide them through the preclinical and clinical phases.